Process Engineer II (426)

Civica - Petersburg, VA

Full-time - Mid Level

Petersburg, VA

51-100 employees

Professional, Scientific, and Technical Services

About the position

The Process Engineer II will play a critical role in bringing the Civica Petersburg, VA facility into a production-ready state, focusing on facility and equipment design through commercialization for a newly announced facility expansion for biologics. This expansion includes a dedicated high-speed cartridge filling line, substantial upgrades to critical utilities services, and dedicated formulation and processing suites equipped with Clean In Place (CIP) and Sanitize In Place (SIP) capabilities. Reporting to the Director of Engineering, Insulin, the Process Engineer II will collaborate extensively with Research & Development, Manufacturing Sciences & Technology (MSAT), Manufacturing, and Quality to develop, transfer, execute, and improve technical transfer processes to meet project and business objectives. During the project delivery and startup phase, which is currently in progress through 2025, the responsibilities of the Process Engineer II will be dynamic. The role will support the startup, build a new organization, and develop and implement the necessary systems and business processes required to support GMP operations while fostering a positive site culture. This will require significant collaboration, creativity, and resilience as the site transitions to full-scale GMP manufacturing. The Process Engineer II will act as a bridge between the project planning phase and ongoing operations by assuming System Owner responsibility for multiple manufacturing systems, with a focus on intermediate support activities and secondary packaging. Equipment areas of ownership will include material transfer to and from automated visual inspection (AVI), collaborating with AVI system owners, laser printing on filled cartridges, and accumulation of pre-filled syringes and cartridges for device assembly. The successful candidate will work closely with Validation, Manufacturing, and Quality Assurance to ensure the availability, support, and maintenance of those systems throughout their lifecycle, serving as a subject matter expert internally and during regulatory inspections for production processes utilizing those systems.

Responsibilities

• Provide technical expertise on CQV activities and ensure compliance with regulatory requirements, industry best practices, and Engineering standards.
• Participate directly in the Engineering process to develop and institute technical and procedural controls in the process design.
• Responsible for developing manufacturing processes considering scale-up factors, calculations, and designing scale-up/engineering batches to optimize manufacturing processes to support exhibit batches.
• Support all CQV activity for assigned systems, including all phases: identifying user requirements, validation planning, protocol generation, test execution, configuration documentation, and system release.
• Execute Engineering deliverables in a timely manner, planning and proactively pursuing details and elevating risks appropriately to ensure project completion without avoidable delays.
• Anticipate operational gaps (improvements to facility/equipment design, process inefficiencies, job hazards) rather than scrambling to fix issues in the project startup, leading to a smoother and safer transition to the Manufacturing team.
• Lead and participate in cross-functional groups to investigate and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.
• Build control strategy documents, technology transfer change controls, engineering, clinical, and PPQ batch protocols in coordination with R&D, ensuring that the manufacturing batch record meets established conditions as defined in the CMC documentation.
• Provide technical support to manufacturing teams at various stages of operations starting from compounding, filtrations, fill and finish, terminal sterilization, and autoclave processes. Troubleshoot and resolve any technical issues that arise on the manufacturing floor.

Requirements

• Bachelor of Science in Pharmaceutical Sciences, Engineering, or a similar technical degree; a post-graduate degree is desired but not required.
• Strong mechanical aptitude with a minimum of 6 years related industry experience, preferably in Sterile Fill Finish, biologics, and material handling.
• Familiarity with scale-up factors and design of process scale-up studies; experience working in an FDA regulated environment.
• Demonstrated ability to solve technical problems and implement projects.
• Excellent interpersonal and communication skills, and fluency in English.
• Self-directed with effective analytical and problem-solving skills; able to deliver results on multiple complex assignments simultaneously in a fast-paced environment.
• Ability to interact well with other functions (e.g., Manufacturing, Automation, Quality Assurance, R&D) and take ownership of and follow through on assigned projects with minimal required direction from supervisors.
• Willingness to adapt to changing priorities as project demands change.

Nice-to-haves

• 6+ years of experience in sterile injectables, drug-device combination products, or biologics.
• SME-level knowledge of drug product and material handling.
• Direct experience ordering capital equipment, materials required for production, spare parts, and calibration and maintenance services.
• Familiarity with cleaning validation and/or process validation.
• Previous work at greenfield sites or substantial facility expansion projects.

Benefits

• Health insurance coverage
• 401k retirement savings plan
• Paid holidays
• Paid time off (PTO)
• Professional development opportunities
• Flexible scheduling options